FDA.reportPublic FDA data

Reagent Set A

Primary DI
07332699000331
Brand
Reagent Set A
Company
M DIALYSIS INC.
Model
Reagent
Catalog number
8002163
Device description
Reagents and Calibrator A for the ISCUSflex analyzer. Contains reagents for Glucose, Lactate, Pyruvate and Glycerol mounted in a cassette.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PPMGeneral Purpose Reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPMGeneral Purpose ReagentPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07332699000331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07332699000331073326990003317332699000331

GMDN Terms#

Term, Definition table
TermDefinition
Microdialysis systemAn assembly of devices intended to be used to monitor local body-tissue chemistry for the early detection of metabolic imbalances and/or cell damage, typically after surgery or during a metabolic disorder. The assembly typically includes a dedicated catheter that is inserted/implanted into tissue (e.g., brain, liver, muscle), a pump that circulates perfusion fluid and interstitial fluid dialysate to and from the site of monitoring, a small vial(s) used to collect samples of dialysate, and an analyser used to determine and display concentrations of analytes (e.g., glucose, lactate, pyruvate) in dialysate samples.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
824632087
Device count
1
DM exempt
true
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07332699000607ISCUSflexClinical80032952016-09-24
0733269900091170 Brain Microdialysis Catheter 60/10, 4/pkg60/10P0000492016-09-24
0733269900092870 Brain Microdialysis Catheter 100/10, 4/pkg100/10P0000502016-09-24
0733269900097370 Microdialysis Bolt Catheter 130/10, 4/pkg130/10P0001312016-09-24
07332699000300Reagent KitReagentP0000112016-09-24
07332699000348Reagent Set BReagent80021642016-09-24
07332699000355Reagent Set CReagent80021652016-09-24
07332699000461Calibrator ACalibratorP0000572016-09-24
07332699000744ISCUSflexClinical80032952016-09-24
07332699000621L-P-G Reagent kitReagent80103612016-09-24
0733269900054670 Brain Microdialysis Catheter 60/10, 4/pkg60/10P0000492016-09-24
0733269900053970 Brain Microdialysis Catheter 100/10, 4/pkg100/10P0000502016-09-24
0733269900057770 Microdialysis Bolt Catheter 130/10, 4/pkg130/10P0001312016-09-24
07332699000034106 Microdialysis Pump106P0000032016-09-24
07332699000058Battery 2x3V, 106 MD Pump10680017882016-09-24
07332699000072106 Syringe10680101912016-09-24
07332699000249Microvial rack 12/pkgRackP0000282016-09-24
07332699000256Microvials 250/pkg250 x MicrovialP0000012016-09-24
07332699000263Perfusion fluid CNSCNSP0001512016-09-24
07332699000287Glutamate reagent5 x Reagent, 5 x BufferP0000642016-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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